The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Auto-field Ii Ophthalmic Field Scanner.
| Device ID | K781462 | 
| 510k Number | K781462 | 
| Device Name: | AUTO-FIELD II OPHTHALMIC FIELD SCANNER | 
| Classification | Perimeter, Automatic, Ac-powered | 
| Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | HPT | 
| CFR Regulation Number | 886.1605 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1978-08-25 | 
| Decision Date | 1978-09-14 |